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A Study to Evaluate Solrikitug in Participants With COPD (ZION)
NCT06496620 · Uniquity One (UNI)
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Randomized, Double-blind, Placebo-controlled, Multiple Dose-Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Participants With Chronic Obstructive Pulmonary Disease (ZION)
About this study
This is a 12-week randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of 2 dose levels of solrikitug versus placebo on top of standard of care in participants with COPD.
Approximately 171 eligible participants with COPD will be randomized at approximately 60-90 sites. Participants will receive solrikitug, or placebo, administered via subcutaneous injection at the study site, over a 12-week treatment period. The study also includes a post-treatment follow-up period of 16 weeks.
Eligibility criteria
Inclusion Criteria:
* At least 40 years of age and no older than 75 years.
* Documented diagnosis of COPD for at least 12 months prior to Screening, defined by the GOLD Guidelines (2023), and elevated blood eosinophils at screening.
* At Screening FEV1/FVC ratio must be \<0.70, and Post-bronchodilator FEV1 must be ≥40% to \<80% predicted normal value calculated using Global Lung Function Initiative (GLI) reference equations (Cooper et al 2017).
* Symptomatic (COPD Assessment Test \[CAT\] Score ≥10) at Screening Visit 1.
* Participants must be on 2 or more inhaled maintenance medications for management of their COPD, for at least 3 months prior to screening.
Exclusion Criteria:
* Female participant who is pregnant or breastfeeding.
* Participant has a known hypersensitivity to any component of the formulation of solrikitug, including any of the excipients, or a history of anaphylactic reaction to any therapeutic monoclonal antibody.
* Participant has history or evidence of any clinically significant cardiovascular, hematologic, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy, or any other condition that in the opinion of the Investigator or Medical Monitor might obfuscate the study data.
* Any other pulmonary disease than COPD that in the opinion of the Investigator, the severity of the disorder would impact the conduct of the study.
* Undergone major lung surgery, within 1 year of Screening Visit 1.
* Participant has a lower respiratory tract infection that required antibiotics within 6 weeks prior to Screening.
Study design
Enrollment target: 171 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-08-14
Estimated completion: 2026-10-31
Last updated: 2026-03-23
Interventions
Biological: Biological: Solrikitug low doseBiological: Biological: Solrikitug high doseOther: Placebo
Primary outcomes
- • Change from baseline in blood eosinophil counts (Through week 12)
Sponsor
Uniquity One (UNI) · industry
With: DevPro Biopharma
Contacts & investigators
ContactUniquity One Clinical Trials · contact · ClinicalTrials@uniquity.com · 484-267-2500
ContactAnushri Walsh · contact · awalsh@devprobiopharma.com · 973-983-3700
InvestigatorAndrew W Lee, MD · study_director, Vice President, Clinical Research
All locations (118)
University of Alabama at Birmingham HospitalRecruiting
Birmingham, Alabama, United States
Syed Research ConsultantsRecruiting
Sheffield, Alabama, United States
Phoenix Medical GroupRecruiting
Peoria, Arizona, United States
Epic Medical Research-SurpriseRecruiting
Sun City, Arizona, United States
Alliance for Multispecialty ResearchRecruiting
Tempe, Arizona, United States
Novak Clinical ResearchRecruiting
Tucson, Arizona, United States
Antelope Valley Clinical TrialsRecruiting
Lancaster, California, United States
Ark Clinical Research - BallingerRecruiting
Long Beach, California, United States
Downtown LA Research Center, Inc.Recruiting
Los Angeles, California, United States
Newport Native MD, Inc.Recruiting
Newport Beach, California, United States
OM ResearchRecruiting
Oxnard, California, United States
Prospective Research Innovations, Inc.Recruiting
Rancho Cucamonga, California, United States
Velocity Clinical Research - DenverRecruiting
Englewood, Colorado, United States
Yale University School of MedicineWithdrawn
New Haven, Connecticut, United States
Access Research InstituteRecruiting
Brooksville, Florida, United States
Innovative Research of West Florida, Inc.Recruiting
Clearwater, Florida, United States
Clinical Research of West Florida - ClearwaterRecruiting
Clearwater, Florida, United States
JY Research InstituteRecruiting
Cutler Bay, Florida, United States
Hillcrest Medical Research, LLCRecruiting
DeLand, Florida, United States
North Florida Foundation for Research and EducationWithdrawn
Gainesville, Florida, United States
Direct Helper Research CenterRecruiting
Hialeah, Florida, United States
Homestead Associates in Research Inc.Recruiting
Homestead, Florida, United States
AppleMed Research Group, LLCRecruiting
Miami, Florida, United States
Y&L Advanced Health Care, Inc.Recruiting
Miami, Florida, United States
Reliant Medical Research LLCRecruiting
Miami, Florida, United States
Valencia Medical & Research CenterRecruiting
Miami, Florida, United States
De La Cruz Research Center, LLCRecruiting
Miami, Florida, United States
Coral Research Clinic CorporationRecruiting
Miami, Florida, United States
Pro-Care Research Center, Corp.Recruiting
Miami Gardens, Florida, United States
San Marcus Research Clinic, Inc.Recruiting
Miami Lakes, Florida, United States
Florida Institute for Clinical ResearchRecruiting
Orlando, Florida, United States
Sarasota Clinical ResearchRecruiting
Sarasota, Florida, United States
TBC ResearchRecruiting
Tamarac, Florida, United States
Clinical Research of West Florida - TampaRecruiting
Tampa, Florida, United States
Appalachian Clinical Research, LLCRecruiting
Adairsville, Georgia, United States
Pulmonology, Sleep, Asthma, and Allergy Center - DublinCompleted
Dublin, Georgia, United States
CPCC - Research, LLCRecruiting
East Point, Georgia, United States
Centricity ResearchRecruiting
Rincon, Georgia, United States
Velocity Clinical Research - BoiseCompleted
Meridian, Idaho, United States
OSF HealthCare Saint Francis Medical CenterRecruiting
Peoria, Illinois, United States
Indiana Medical Research InstituteCompleted
Merrillville, Indiana, United States
The University of Kansas Medical CenterWithdrawn
Kansas City, Kansas, United States
The Research Group of Lexington, LLCCompleted
Lexington, Kentucky, United States
Tandem Clinical ResearchRecruiting
Metairie, Louisiana, United States
Care Access - ShreveportRecruiting
Shreveport, Louisiana, United States
Mayflower ClinicalRecruiting
South Dartmouth, Massachusetts, United States
Revival Research Institute, LLCRecruiting
Dearborn, Michigan, United States
Henry Ford Health SystemRecruiting
Detroit, Michigan, United States
Pulmonary Research Institute of SE MichiganRecruiting
Farmington Hills, Michigan, United States
Revive Research InstituteRecruiting
Southfield, Michigan, United States
Midwest Chest ConsultantsNot Yet Recruiting
Saint Charles, Missouri, United States
Montana Medical Research, Inc.Recruiting
Missoula, Montana, United States
Henderson TrialsRecruiting
Henderson, Nevada, United States
Rutgers, The State University of New JersyRecruiting
New Brunswick, New Jersey, United States
Certified Research Associates Finger Lakes Medical Research, LLCRecruiting
Cortland, New York, United States
Corning Center for Clinical Research Smith Allergy & Asthma SpecialistsRecruiting
Horseheads, New York, United States
Northwell HealthWithdrawn
New Hyde Park, New York, United States
OnSite Clinical SolutionsRecruiting
Charlotte, North Carolina, United States
Clinical Research of GastoniaRecruiting
Gastonia, North Carolina, United States
Triad Clinical TrialsRecruiting
Greensboro, North Carolina, United States
Peters Medical ResearchRecruiting
High Point, North Carolina, United States
Advanced Respiratory and Sleep MedicineRecruiting
Huntersville, North Carolina, United States
Accellacare WilmingtonCompleted
Wilmington, North Carolina, United States
Southeastern Research CenterRecruiting
Winston-Salem, North Carolina, United States
MetroHealth Medical CenterWithdrawn
Cleveland, Ohio, United States
Remington DavisRecruiting
Columbus, Ohio, United States
NexGen ResearchRecruiting
Lima, Ohio, United States
OK Clinical ResearchRecruiting
Edmond, Oklahoma, United States
Velocity Clinical Research - Grants PassCompleted
Grants Pass, Oregon, United States
Velocity Clinical Research - MedfordRecruiting
Medford, Oregon, United States
Clinical Research Associates of Central PARecruiting
DuBois, Pennsylvania, United States
Temple UniversityRecruiting
Philadelphia, Pennsylvania, United States
University of Pittsburgh/UPMCRecruiting
Pittsburgh, Pennsylvania, United States
Allergy and Clinical Immunology AssociatesRecruiting
Pittsburgh, Pennsylvania, United States
AnMed HealthRecruiting
Anderson, South Carolina, United States
Velocity Clinical Research - AndersonRecruiting
Anderson, South Carolina, United States
Medical University of South CarolinaRecruiting
Charleston, South Carolina, United States
Velocity Clinical Research - ColumbiaRecruiting
Columbia, South Carolina, United States
Velocity Clinical Research - GaffneyRecruiting
Gaffney, South Carolina, United States
Velocity Clinical Research - GreenvilleCompleted
Greenville, South Carolina, United States
Clinical Research of Rock HillRecruiting
Rock Hill, South Carolina, United States
Velocity Clinical Research - SpartanburgRecruiting
Spartanburg, South Carolina, United States
Velocity Clinical Research - UnionRecruiting
Union, South Carolina, United States
Pulmonary & Sleep SpecialistsCompleted
Dickson, Tennessee, United States
Premier Research Center, LLCRecruiting
Hendersonville, Tennessee, United States
New Phase Research & DevelopmentRecruiting
Knoxville, Tennessee, United States
TTS ResearchNot Yet Recruiting
Boerne, Texas, United States
Proactive RGVRecruiting
Brownsville, Texas, United States
Ten20 Clinical Research, LLCRecruiting
Carrollton, Texas, United States
IntraCare Health CenterRecruiting
Dallas, Texas, United States
IntraCare ClinicalRecruiting
Greenville, Texas, United States
Axsendo Clinical ResearchCompleted
Houston, Texas, United States
Gulf Coast Clinical ResearchRecruiting
Houston, Texas, United States
R & H Clinical ResearchRecruiting
Katy, Texas, United States
IntraCare Health CenterRecruiting
McKinney, Texas, United States
SMS Clinical ResearchRecruiting
Mesquite, Texas, United States
ADP Clinical ResearchRecruiting
Splendora, Texas, United States
Alpine Research Organization, Inc.Recruiting
Layton, Utah, United States
Velocity Clinical Research - HamptonRecruiting
Hampton, Virginia, United States
Core ClinicalWithdrawn
Everett, Washington, United States
Confluence HealthWithdrawn
Wenatchee, Washington, United States
Momentum TaringaRecruiting
Taringa, Brisbane, Australia
Northside HealthRecruiting
Coffs Harbour, New South Wales, Australia
Momentum St. LeonardsRecruiting
Sydney, New South Wales, Australia
Momentum Wellers HillCompleted
Tarragindi, Queensland, Australia
Dr. Syed Anees Medicine Professional CorporationWithdrawn
Windsor, Ontario, Canada
Pacific Clinical Research Network Auckland - PCRN West AucklandRecruiting
New Lynn, Auckland, New Zealand
Momentum WellingtonRecruiting
Mount Cook, Wellington Region, New Zealand
Pacific Clinical Research Network Auckland - PCRN AucklandRecruiting
Auckland, New Zealand
New Zealand Respiratory & Sleep Institute (NZRSI)Recruiting
Auckland, New Zealand
Momentum Hawke's BayCompleted
Hastings, New Zealand
Momentum TaurangaRecruiting
Tauranga, New Zealand
Momentum KapitiRecruiting
Waikanae, New Zealand
The Medicines Evaluation Unit, an IQVIA businessRecruiting
Wythenshawe, Manchester, United Kingdom
Bradford Teaching Hospitals NHS Foundation TrustRecruiting
Bradford, United Kingdom
Velocity Clinical Research High WycombeRecruiting
High Wycombe, United Kingdom
Velocity Clinical Research - BristolRecruiting
London, United Kingdom
Queen Anne Street Medical CentreRecruiting
London, United Kingdom